Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed 11/24/25 is entered. Claims 2, 5 and 15-28 is rejected. Claim 29 is new. Claims 1, 3-4, 6-14, and 29 are pending and are under examination.
The indicated allowability of claim 5 is withdrawn in view of the newly discovered reference(s) to Frazer et al. WO 2006/108241 10/19/2006. Rejections based on the newly cited reference(s) follow.
Information disclosure statement filed 11/24/25 has been considered and an initialed copy is enclosed.
The rejection of claim(s) 1, 3-4 and 6-14 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Thanos et al. US 2019/0017050 1/17/19 cited in IDS 7/11/22 is withdrawn in view of the amendment to the claims.
The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of claim 4 is not clear. The specification at paragraph 7 teaches that the condition associated with an increased risk of benign nervous system tumor is NF1, NF2 and schwannomatosis however claim 1 recites that the benign nervous system tumor is NF1, NF2 and schwannomatosis. Elsewhere in the specification at paragraph 3 NF2 and schwannomatosis is referred to as a debilitating genetic syndrome. In paragraph 14, the specification teaches that the tumor includes, but is not limited to those associated with neurofibromatosis type 1, neurofibromatosis type 2 and schwannomatosis. Please clarify whether these conditions are the benign nervous system tumors or are the conditions associated with an increased risk of having a benign nervous system tumor.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 fails to further limit the scope of claim 1 because the subject in claim 1 does not have a malignant solid tumor e.g. NF1, NF2 and schwannomatosis.
Claim 4 fails to further limit the scope of claim 1 because in the specification at paragraph 7 art teaches that the condition associated with an increased risk of benign nervous system tumor is NF1, NF2 and schwannomatosis which are already recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-4, 6 and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the Frazer et al. WO 2006/108241 10/19/2006 as evidenced by Cao et al US 2012/0157401.
1. Frazer et al disclose a method of a treating a subject having or at risk of having a benign nervous system tumor, the method comprising administering to the subject a therapeutically effective amount of a composition comprising live attenuated Salmonella bacteria (paragraph 110),
Thus, Frazer et al disclose treatment of neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2), schwannomatosis or any combination thereof.
Claim 3: Frazer et al disclose the subject has N1, NF2, schwannomatosis or any combination thereof which are not a malignant solid tumor.
Claim 4: Frazer et al disclose the subject has N1, NF2, schwannomatosis or any combination thereof, thus the subject has a condition associated with an increased risk of having a benign nervous system tumor.
Claim 6: Frazer et al disclose the attenuated Salmonella is administered intravenously.
Claim 9: Frazer et al does not disclose the composition comprises Clostridium novyi.
Claim : 10. Frazer et al does not disclose that the attenuated Salmonella comprises a lysis gene or cassette operably linked to an intracellularly induced Salmonella promoter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazer et al. WO 2006/108241 10/19/2006 as evidenced by Cao et al US 2012/0157401 in view of Portnoy et al. US 6004815 12-21-1999.
Frazer et al disclose a method of a treating a subject having or at risk of having a benign nervous system tumor, the method comprising administering to the subject a therapeutically effective amount of a composition comprising live attenuated Salmonella bacteria (paragraph 110),
Thus, Frazer et al disclose treatment of neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2), schwannomatosis or any combination thereof.
Frazer et al does not disclose the Salmonella is Salmonella typhimurium.
Portnoy et al teaches that Salmonella typhimurium can be used as an intracellular delivery vehicle. See whole of Portnoy et al especially table 1.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have modified Frazer et al to use live attenuated Salmonella typhimurium for intracellular delivery in the manner disclosed by Frazer et al for treating neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2) and schwannomatosis, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Frazer et al discloses the live attenuated Salmonella for treating neurofibromatosis 1 (NF1), neurofibromatosis 2 (NF2) and schwannomatosis and Portnoy et al disclose that Salmonella typhimurium can be used as an intracellular delivery vehicle.
Claim(s) 1, 7, 8, 11-14 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazer et al. WO 2006/108241 10/19/2006 as evidenced by Cao et al US 2012/0157401 in view of Thanos et al. US 2019/0017050 1/17/19 cited in IDS.
Frazer et al as evidenced by Cao et al is set forth above but does not disclose the use of a live attenuated Salmonella typhimurium strain VNP20009 which has a modified lipid A (msbB-) and purine autotrophic mutation (purI) as disclosed by the instant specification. Frazer et al as evidenced by Cao et al does not disclose further administering the live attenuated bacteria in combination with an immune checkpoint inhibitor and/or an angiogenesis inhibitor.
Thanos et al disclose the use of live attenuated Salmonella typhimurium VNP20009 in treating cancer/tumors (see abstract, paragraph 9, 17, 20, 71 and 414-415).
Thanos et al disclose the live attenuated Salmonella typhimurium is administered with checkpoint inhibitor is an antibody that binds PD-L1 or CTLA-4. See paragraph 71.
Thanos et al discloses live attenuated Salmonella typhimurium is administered with Bevacizumab an anti-VEGF antibody. See paragraph 414-415.
It would have been prima facie obvious to a person of ordinary skill in the art to have modified the method of Frazer et al by administering live attenuated Salmonella typhimurium such as strain VNP20009 and further administering an immune checkpoint inhibitor and/or an angiogenesis inhibitor as taught by Thanos et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Thanos et al disclose that live attenuated Salmonella typhimurium such as VNP20009 can be used in treating cancer/tumors and as a combination therapy an immune checkpoint inhibitor and/or an angiogenesis inhibitor is administered.
Status of Claims
Claims 1, 3-4, 6-14, and 29 are rejected.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645